[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636834":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":11,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":11,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":11,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":11,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":11,"overallStatus":74,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8,15,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-dose group","EXPERIMENTAL",null,[13,14],"Biological: Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs)","Biological: Normal Saline Placebo",{"label":16,"type":10,"description":11,"interventionNames":17},"Moderate-dose group",[13,14],{"label":19,"type":10,"description":11,"interventionNames":20},"High-dose group",[13,14],[22,27],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"BIOLOGICAL","Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs)","hUCMSC-EVs , nebulized BID × 7d\u002Fcycle, 3 cycles",[19,9,16],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"Normal Saline Placebo","Nebulized inhalation BID × 7d per cycle, 3 cycles",[19,9,16],[32],{"name":33,"role":34,"phone":35,"phoneExt":11,"email":36},"Tong, M.D","CONTACT","86-13764089607","tong.lin@zs-hospital.sh.cn",[38],{"facility":39,"status":11,"city":40,"state":11,"zip":11,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Zhongshan Hospital, Fudan University","Shanghai","China","CN",{"type":44,"coordinates":45},"Point",[46,47],121.45806,31.22222,{"lat":47,"lon":46},[50,51],{"name":33,"role":34,"phone":35,"phoneExt":11,"email":36},{"name":52,"role":53,"phone":11,"phoneExt":11,"email":11},"Yuanlin Song, M.D","PRINCIPAL_INVESTIGATOR",{"type":55,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100636834","phase-1-safety-and-preliminary-efficacy-of-hucmsc-evs-in-interstitial-lung-disease-100636834",false,"NCT07570836","Safety and Preliminary Efficacy of hUCMSC-EVs in Interstitial Lung Disease","A Clinical Study to Explore the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles in the Treatment of Interstitial Lung Disease","Key Inclusion Criteria:\n\n* Age 18 years and older, regardless of gender.\n* Diagnosed with interstitial lung disease (ILD).\n* High-resolution computed tomography (HRCT) findings within 3 months prior to randomization must be consistent with interstitial pulmonary imaging changes.\n* Pulmonary function test within the protocol-defined acceptable range prior to randomization.\n* Good compliance, able to understand and cooperate with the required examinations and procedures, and willing to attend follow-up visits as scheduled.\n* Voluntary participation and signing of written informed consent form.\n\nKey Exclusion Criteria:\n\n* Inability to tolerate nebulized inhalation therapy.\n* Requirement for oxygen supplementation \\> 15 hours per day during the screening period.\n* Allergic diathesis or a history of life-threatening drug hypersensitivity.\n* History of malignancy within 5 years.\n* Active hepatitis B, hepatitis C, or HIV infection.\n* Active systemic infection requiring antibiotic therapy.\n* Clinically significant laboratory abnormalities at screening.\n* Concomitant significant or severe respiratory disease.\n* History of psychiatric illness, epilepsy, or other central nervous system disorders.\n* Concomitant severe cardiovascular, hepatic, or renal systemic disease.\n* Pregnancy, planned pregnancy in the near future, or breastfeeding.\n* Unwillingness to use effective contraception during the study period.\n* Any condition that, in the opinion of the investigator, may increase the risk to the participant or interfere with the study outcomes.","ALL","18 Years",{"count":66,"type":67},24,"ESTIMATED","INTERVENTIONAL",[70],"PHASE1","This is an exploratory, randomized, single-blind, placebo-controlled, multiple-dose, dose-escalation clinical study. The study aims to evaluate the safety and preliminary efficacy of nebulized inhalation of Human Umbilical Cord Mesenchymal Stem Cell-Derived Extracellular Vesicles (hUCMSC-EVs) in patients with interstitial lung disease (ILD).\n\nThis study is designed to include three sequential dose cohorts-low, medium, and high-with dose escalation proceeding in an ascending order. Eligible subjects will be enrolled and randomized sequentially, with a planned enrollment of 8 subjects per cohort. Within each cohort, subjects will be randomly assigned in a 3:1 ratio to receive either hUCMSC-EVs or saline placebo.",[73],"Interstitial Lung Disease (ILD)","NOT_YET_RECRUITING","2026-05-01",{"date":77,"type":78},"2026-05-06","ACTUAL",{"date":80,"type":67},"2026-04-30",{"date":82,"type":67},"2028-09-30",{"name":5,"class":6},1]